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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
Assays from different vendors can generate different values. This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used. This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, the elecsys tsh assay ver. 2, and the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers. The results measured at the customer site were reported outside of the laboratory to a physician. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay. Refer to the attachment for all patient data. The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021. The sample was repeated for tsh on the customer's e 801 analyzer after dilutions. The sample was also treated with a 25 % polyethylene glycol (peg) solution and repeated on the customer's e 801 analyzer. The sample was repeated using the wako accuraseed method and the abbott architect method. The sample was provided for investigation, where it was tested using a second e 801 analyzer on (b)(6) 2021. The serial number of the customer's e 801 analyzer is (b)(4). The tsh reagent lot number and expiration date used on this analyzer was requested, but not provided. The serial number of the e 801 analyzer used for investigation is (b)(4). Tsh reagent lot number (b)(4), with an expiration date of may 2021 was used on this analyzer.
 
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Brand NameELECSYS TSH ASSAY
Type of DeviceRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key11375155
MDR Text Key252849045
Report Number1823260-2021-00563
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number07028091190
Device Lot NumberASKU, 454296
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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